A Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022



Status:Recruiting
Conditions:Shingles, Infectious Disease
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases
Healthy:No
Age Range:50 - Any
Updated:10/14/2018
Start Date:October 20, 2010
End Date:April 26, 2019
Contact:US GSK Clinical Trials Call Center
Email:GSKClinicalSupportHD@gsk.com
Phone:877-379-3718

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Observational Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022 and HZ Efficacy, Immunogenicity and Safety of HZ/su by Frailty Status

As part of the ZOSTER-006 and ZOSTER-022 pivotal trials of the HZ/su vaccine, all study
participants completed quality of life (QoL) questionnaires. The only questionnaires encoded
into the data base were those from participants who developed a suspected shingles episode
during the study.

The purpose of this study is to allow for the encoding and analysis of questionnaires for all
subjects enrolled in ZOSTER-006 and ZOSTER-022. The aim is to assess the baseline frailty of
subjects enrolled in these studies and to investigate whether this population is
representative of the general population.

As part of the study procedure, each subject enrolled in studies Zoster-006 and Zoster-022
was asked to complete two quality of life (QoL) questionnaires named respectively SF-36 and
EQ-5D at predefined study time points. These questionnaires were to provide relevant
information about the quality of life (functional status, ability to socialize, mental
health, etc.) of subjects before they develop shingles Extracting some elements of the
Quality of Life questionnaires (QoL), EQ-5D and SF-36, completed by all study subjects at
baseline, and combining them with other medical history data allows attributing of frailty
scores.

Analyses pertaining to efficacy, safety and immunogenicity as per frailty score might be
performed according to the methodology used in the ZOSTER-006 and ZOSTER-022 studies.

Additionally, the data collected can be used to assess if some physical, physiological and/or
psychological characteristics reported by the subjects before the onset of HZ would be
predictive of HZ.

Inclusion Criteria:

- All subjects who participated in the Zoster 006 and Zoster 022 trials.

- Subjects who died or were lost to follow-up during ZOSTER-006 and ZOSTER-022 will be
considered for enrolment in ZOSTER-064 and their data/questionnaires up to that point
will be used.

Exclusion Criteria:

- Subjects who were excluded from all analyses from ZOSTER-006 and ZOSTER-022. This will
include any subject eliminated following deviations from GCP compliance.

- Subjects who developed a suspected HZ case during ZOSTER-006 and ZOSTER-022 (since
their QoL questionnaires were encoded in the eCRF for ZOSTER-006 and ZOSTER-022).
We found this trial at
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